No sanctions over deficiencies at California virus test lab

SACRAMENTO (Calif.) -- California's coronavirus testing laboratory will not be subject to sanctions for "significant deficiencies" that a whistleblower claimed threatened its accuracy, authorities announced Monday.

No sanctions over deficiencies at California virus test lab

SACRAMENTO (Calif.) -- California's coronavirus testing laboratory will not be subject to sanctions for "significant deficiencies" that a whistleblower claimed threatened its accuracy, authorities announced Monday.

According to the California Department of Public Health, (CDPH), although the Valencia Branch Laboratory was found to be having problems with record-keeping and training, authorities were unable to support reports that the laboratory had destroyed documents or data.

According to the department, the problems were found "routinely in laboratory inspections."

The agency stated that "all deficiencies were addressed" and that there was no impact on the integrity of the laboratory tests. Therefore, sanctions will not be imposed.

The lab, which cost $25 million, opened north of Los Angeles in October 2020. A preliminary report by the state stated that only 1% of more than 1.5million tests had been processed.

Last month, the Laboratory Field Services division of the health department issued a notice indicating its intention to impose sanctions. However, just 10 days later, the state renewed a $1.7 billion no-bid contract to run the laboratory with PerkinElmer in Massachusetts.

Because PerkinElmer had fixed its problems, the threat of sanctions was lifted earlier in the month.

PerkinElmer stated that it worked with the state department of public health to address concerns. It was happy that the laboratory was found to be in compliance with all state laws and regulations.

The statement stated that "This is further proof that PerkinElmer & CDPH remain steadfastly focussed on operating a best in-class laboratory for California residents".

According to the public health department, the automatic renewal of the contract was allowed because there was concern that winter might bring another COVID-19 spike. The state can still terminate the contract at its discretion, if it so chooses.

Partly, inspectors had attributed problems at the laboratory to the fast ramp-up that they demanded from the operator. It was difficult to obtain COVID-19 test results at the time, and it was sometimes impossible to do so. Sometimes they were delayed until it became too late.

The department also conducted a routine inspection. It investigated whistleblower complaints of incompetence or mismanagement.

CBS13 TV in Sacramento obtained records that alleged problems such as swapped samples, inconclusive testing due to contamination and incorrect results being sent to patients.

The lab sued the whistleblower because he violated a confidentiality agreement.

Federal investigation continues into the lab.

The laboratory was also recognized by the public health department as having played a critical role in increasing access to testing for those at high risk of COVID-19. This included essential workers and residents of disadvantaged and minority communities.

A department statement stated that the laboratory had performed more than 5.5 millions tests on samples collected from more than 4,700 sites, which were developed in collaboration with churches, schools and clinics, essential workplaces, and community-based groups.

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